CDC is working with state health departments, FDA, and Aziyo Biologics to respond to a new cluster of tuberculosis (TB) cases linked to suspected contaminated viable bone matrix material used primarily in spinal fusion back surgeries and dental surgeries. These procedures used a single product lot of a viable bone matrix material manufactured by Aziyo Biologics (lot #TDS222820) with an expiration date of November 2, 2024. On July 13, 2023, the manufacturer proactively issued a voluntary nationwide recall of the product from this lot.
Patients who received ViBone or alloOss units from lot TDS222820 should be clinically evaluated as soon as possible both for post-operative infection as well as TB disease. CDC recommends that patients who underwent surgery or dental procedures involving this product lot receive a complete diagnostic evaluation for tuberculosis and begin 4-drug treatment for a presumptive diagnosis of drug-susceptible TB disease, even in the absence of signs or symptoms of disease.
Healthcare personnel may have been exposed to TB bacteria via exposure to potentially contaminated material during surgery or surgical revision or when providing patient care or processing medical waste and surgical instruments. It will also be important to identify and assess all exposed healthcare contacts for TB infection and disease. CDC will provide additional guidance as more information is available.
For any questions, please reach out to your CDC project officer, or contact HAIoutbreak@cdc.gov.